# P100024: HER2 Cish Pharmdx Kit

- Pathway: PMA
- Applicant: Dako Denmark A/S
- Decided: Nov 30, 2011 after 527 days
- Product code: NYQ (Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 21, 2014 · Class II · Z-1093-2014: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.

Source page: https://510kreport.com/device/P100024
Methodology: https://510kreport.com/methodology